'Recruitment etiquette' may be new buzz phrase in subjects' protection

Face-to-face meetings are best

All it takes is for an IRB member or investigator to experience those intrusive, evening phone calls about a new study enrolling people with their health condition to convince them that there must be a better way to approach potential research participants.

"Recruitment etiquette is a big issue," says Kimberley Hunt, MA, a research consultant in Montreal, Canada.

Investigators might think their explanations of a study are straightforward and simple, but their ideas often are lost in the translation by the time they begin the subject recruitment process, she notes.

Research organizations also could improve their study enrollment patterns by following research etiquette strategies, experts say.

"Recruitment is a problem on a national scale, and thinking about this issue of research etiquette has brought us to the idea that we could probably enhance recruitment if we paid more attention to this area," says Monika Markowitz, PhD, director of the office of research compliance and education in the vice president's office of research at Virginia Commonwealth University (VCU) in Richmond, VA.

Recruitment etiquette also is a more respectful way to deal with potential research participants.

"I've been someone taking those night calls, and I have concerns about invasion of privacy," says Dale E. Hammerschmidt, MD, an associate professor of medicine at the University of Minnesota in Minneapolis, MN. Hammerschmidt sat on IRBs for 25 years and was a chair for about half of that time. Currently, he's the due diligence officer in the department of medicine and chairs a scientific merit review committee at the University of Minnesota.

People need uninterrupted private time, and they can suffer from study recruitment attempts, he says.

"I've had patients yell at me when they were approached about a study inappropriately," Hammerschmidt says.

People always ask where the study recruiters got their names because they had assumed that their doctor-patient confidentiality had extended broadly across health care encounter settings, he adds.

"Calls are particularly a problem because a person doesn't have time control over them," he says. "If someone works nights and needs to sleep at 5:30 in the afternoon, then a phone call at that time is something they're not going to appreciate."

Mail is less intrusive. But it can be a problem if it's opened by someone other than the potential research subject, and the person's disease is disclosed in the letter.

"When you have face-to-face communication with potential participants, you do not get the violation of trust that people might feel if they were being called or if they received a letter out of the blue," Markowitz says.

"Cold calling is something that happens a lot in research, and we do not usually permit it at VCU," she adds.

As a VCU genetic counselor and research coordinator, Maria Gyure, MS, CGC, has had extensive training in developing rapport with clients.

"Genetic counselors communicate in person-first language, and that means thinking about the person first and not their disease," she explains. "For example, instead of saying, 'A Down's child,' you say a child with Down Syndrome."

One strategy for improving recruitment etiquette is to create a standardized recruitment document for each protocol. It would provide detailed information about inclusion/exclusion criteria, anticipate potential subjects' and IRB members' questions and concerns, and collect demographic data that could be used during later study analyses, Hunt suggests.

Hammerschmidt, Gyure, and Hunt recently discussed recruitment etiquette on the IRB Forum at www.irbforum.com.

One of Hammerschmidt's chief suggestions is that investigators should make certain that private medical information of potential subjects who also are patients are not given to anyone who would not ordinarily have access to it without the patients' permission.

Also, investigators and study recruiters should approach people in a manner that is acceptable to them. This is information that can be discovered well in advance.

For instance, physicians could ask their patients these sorts of questions:

  • "We often do research studies. Is it okay if we contact you about possibly being involved in a study?"
  • "How do you like to be contacted? Would you prefer email, post office mail or telephone calls?"
  • "Are there times of the week or day that would be bad to call you?"

It's always better if potential research subjects are asked about their interest in research in a face-to-face encounter, rather than in the impersonal method of putting a sentence about research in a long medical form they have to sign, Hammerschmidt notes.

"I had an unfortunate experience at a restaurant and had to go to the emergency room where I was given a packet with various things, and on page 15 of 22 pages there was a question about research," he recalls. "I was mad they did it in that way and crossed it out. But I would have been happy to say 'Yes' if they had asked me politely in person."

The other advantage of face-to-face encounters is that they give recruiters nonverbal cues as to the potential participant's feelings and thoughts.

"Body language does affect a lot of what we do in terms of recruitment, and sometimes that's all we have to go on," Gyure says. "If a participant sits with arms crossed or if they appear to be leery of what you have to say, then you have to address it."

Someone in the potential subject's circle of confidentiality should make the initial recruitment contact. This can be done broadly with the physician or nurse saying, "We're doing clinical studies on your disease, and it might turn out you're eligible. Could we have someone give you a call?" Hammerschmidt suggests.

Patients typically say 'Yes' when approached in this personal way, so better recruitment etiquette could also help with improving recruitment, he notes.

"If you have affronted them by the way you contacted them, then they're often very unhappy," he says.

Hammerschmidt dismisses the concern some physicians have about in-person discussions of research taking too long.

"People overestimate how much time it takes," he says.

Gyure has recruited subjects in a women's clinic by approaching them to ask if they are waiting to see the doctor or nurse. She speaks in a soft tone, looks people in the eyes, and sits or squats down to be at their eye level.

If the waiting room is crowded, she'll suggest the person join her in a second room where there are fewer people. The study for which she recently was enrolling participants needed women of any health status to discuss family communication about cancer, whether or not it impacts them personally.

"I say, 'My name is Maria, and I'm one of the researchers here at VCU,'" Gyure says. "Then I tell them that we're doing a study on family communication in cancer, and I ask if they'd like to hear more about it."

Once Gyure receives a nod in affirmative, she discusses the study and assures them that people who participate in the study do not have to be diagnosed with cancer, nor have a family history of cancer.

"I say, 'We're looking for all types of families and how they communicate with each other and how they function,'" she explains.

One other aspect of recruitment etiquette that often is overlooked involves how a clinical trial recruiter handles himself or herself when in the company of other research recruiters.

"We recruit in a women's health clinic where multiple other studies are recruiting," Gyure says. "When you are with other recruiters it's important to identify yourself to them and work together when possible."

For instance, there are some studies that recruit from the same patient population, and various study recruiters could make referrals based on people they know who did not meet one study's criteria but might meet another one's, she adds.

Also, it's important that recruiters do not overwhelm patients in a doctor's office and avoid approaching someone who already has said "No" to another recruiter, Gyure says.

"We try to find someone who has not been approached," she adds.